The efficacy of EPA-DHA supplementation will be assessed in a randomized placebo-controlled trial with cognitive decline and early signs of depression as primary outcome measures. In this study 300 elderly people will be randomly allocated to one of three treatments. Two groups will receive fish oil capsules with different doses EPA/DHA (a normal dose or a high dose) and the third group will receive placebo capsules. At the start and at the end of the intervention period cognitive function, the occurrence of depression, quality of life, anthropometric values and biochemical indicators will be measured.

After completion of the trial a workshop will be organized in which the outcomes of the proposed study will be presented to representatives of several key areas concerning mental health of elderly people.

Eligibility

Ages Eligible for Study:

65 Years and older (Adult, Senior)

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Criteria

Inclusion Criteria:

Men and women

Aged 65 years and over

Informed consent signed

Exclusion Criteria:

A score of > 16 on the CES-D (Centre for Epidemiological Studies-Depression Scale

A score of < 21 points on MMSE (Mini-Mental State Examination)

Current or recent (<4 weeks) use of fish oil supplements or intake of more than 4 times fish as judged by a fish consumption questionnaire

Current use of pharmacological antidepressants

Current use of dementia (Alzheimer) medication

Serious liver disease

Use of more than 4 glasses of alcohol per day

Unable to participate as judged by the responsible medical physician

Allergy to fish(oil)

Swallowing problems

Participation in another clinical trial less than 2 months before the start of the trial or at the same time

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00124852

Locations

Netherlands

Wageningen University

Wageningen, Gelderland, Netherlands, 6700 EV

Sponsors and Collaborators

ZonMw: The Netherlands Organisation for Health Research and Development